Topical therapeutic composition and palliative treatment method

ABSTRACT

Disclosed herein is a topical therapeutic composition and method for the palliative treatment of irritated or inflamed perianal tissue. The therapeutic composition comprises olive oil and tea tree oil. The palliative treatment of the invention involves application of the composition to irritated or inflamed perianal tissue. The composition and method of the invention can be employed in the palliative treatment of such human maladies as hemorrhoids, fissures and pruritis ani.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a Divisional of U.S. patent application Ser. No.13/507,719, filed Jul. 21, 2012, and claims the benefit of U.S.Provisional Application Ser. No. 61/628,217, filed by the presentapplicant on Oct. 26, 2011. The disclosure of U.S. patent applicationSer. No. 13/507,719 is expressly incorporated by reference herein in itsentirety.

BACKGROUND OF THE INVENTION

The present invention relates broadly to a topical therapeuticcomposition and is more particularly concerned with a composition whichis therapeutically effective when topically applied to irritated orinflamed perianal tissues such as occur in such ano-rectal conditions ashemorrhoids (also known as “piles”), fissures, pruritus ani and thelike.

Among the more bothersome conditions of Man are those which involve theirritation or inflammation of the perianal tissue. Not only is thephysical discomfort of soreness and burning sensation involved, but alsothere often occur severe emotional issues and social stigmas attendantthe sufferer's almost universal compelling urge to repeatedly scratchand touch the affected area. The more common of these conditions arehemorrhoids, fissures and pruritus ani.

Hemorrhoids are swollen veins in the lower portion of the rectum or anusand usually result from increased intravenous pressure such as can occurduring pregnancy, childbirth, sitting for extended periods, excessivestraining during defecation and chronic diarrhea or constipation.Internal hemorrhoids occur just inside the anus, but may protrudethrough the anal opening. External hemorrhoids occur just outside theanal opening. Hemorrhoidal symptoms include itching of or pain in theperianal tissue, particularly when sitting or defecating, the presenceof frank blood on toilet tissue or toilet bowl and the presence oftender lumps in the perianal tissue.

Fissures are simply tears in the anal or perianal tissue, usuallybrought about by the passage of hard, oversize stools through the analopening. Pain and bleeding are the usual symptoms of the presence offissures.Pruritus ani is a condition characterized by a chronic itching of theperianal tissue of such severity that the afflicted suffer a compellingurge to scratch the affected tissue, often with accompanying burning andsoreness. Causatives of this condition are varied, ranging from anexcessively moist local environment such as caused by perspiration, toinfectious attack, such as in Candidiasis. In some people, the intake ofirritating foods, such as coffee, tea, carbonated beverages, tomatoesand the like, may cause or at least contribute to the severity of thiscondition. In accordance with the invention, I have discovered acomposition which, when topically applied to the affected area,functions as a palliative, thereby to sooth and promote healing ofirritated or inflamed perianal tissue.

OBJECTS OF THE INVENTION

It is a principal object of the present invention to provide a noveltopical therapeutic composition.

It is another object of the invention to provide a novel method for thepalliative treatment of irritated or inflamed perianal tissue.

Other objects and advantages of the invention will, in part, be obviousand will, in part, appear hereinafter.

SUMMARY OF THE INVENTION

The topical therapeutic composition of the invention broadly comprisesolive oil and between about 0.001 to about 10% by volume of tea treeoil. I generally prefer a composition wherein the concentration of thetea tree oil component is about 5% by volume.

The palliative treatment method of the invention comprises applying thecomposition of the invention to irritated or inflamed perianal tissue.

DETAILED DESCRIPTION OF THE INVENTION

Olive oil is the extract of the olive (Olea europaea) and is generallyproduced by first grinding the ripe olive fruit into a paste and thenextracting the oil from the ground paste by mechanical or chemicalmeans, In general, for the composition of the invention I prefer anolive oil component which is derived from the ground paste solely bymechanical means (virgin olive oil), such as by pressing orcentrifugation.

Due to its chemical makeup and physical properties the olive oilcomponent of the invention contributes meaningfully to the overallpalliative therapeutic effect achieved by the composition of theinvention when applied topically to an irritated or inflamed perianaltissue. For instance, its oily consistency permits it to act as alubricant and to thereby reduce the pain and itching associated withthis condition. Too, its oleophilic nature acts as a barrier to waterwhich is highly desirable to promote healing of irritated and/orinflamed perianal tissue. Too, its mildly acidic pH roughly matches thep″ of healthy perianal tissue and thus serves to maintain this normalcondition of acidity, thereby also fostering the healing process.Additionally, olive oil contains substantial amounts of antioxidants andvitamins, particularly vitamins A, E and K, and all of which cancontribute substantially to the nourishment of the perianal epitheliumas it undergoes the healing process.

Tea tree oil is the oily extract produced commercially by distillationof tea tree (Melaleuca alternafolia) plant material and, to a lesserextent, by distillation of Melaleuca dissitiflora or Melaleucalinarafolia plant materials. Tea tree oil has very substantialantiviral, antibacterial, antifungal and antiseptic properties and it isthese properties which serve in the composition of the invention tominimize infectious attack on the perianal tissue as it heals. Thus, thecomponents of the composition of the invention cooperate to provide asalubrious environment whereby the healing process of the perianaltissue can proceed at maximum pace and with minimum risk of secondaryinfection. In use the therapeutic composition of the invention, aspreviously mentioned, is topically applied to the affected inflamedperianal tissue. This can be done by direct digital manipulation or byuse of pledgets, gauze pads, cotton balls and the like saturated withthe composition. Also contemplated is the use of various applicatordevices known in the art. In the treatment of internal hemorrhoids afelted tampon can be saturated with the composition of the invention andthen inserted into the anal canal. In addition, by blending withappropriate thickening agents, such as fumed silica, the composition ofthe invention can be converted to a form stable solid, suitable forconformation into a suppository shape and used as such.

The therapeutic composition of the invention, in addition to its oliveoil and tea tree oil components, can also comprise additionalmedicaments and modifiers. For instance, the basic olive oil/tea treeoil composition can be physically modified by emulsifying it with anaqueous phase, thereby to result in a composition having the physicalform of a lotion, salve, cream or the like. Too, additional medicamentscan be dissolved into the oil phase or, if present, the aqueous phase ofthe composition. Exemplary of such additional suitable medicaments areone or more of the following: local anesthetics such as benzocaine,pramocaine, lidocaine or tetracaine; vasoconstrictors such as ephedrinesulfate or phenylephrine; protectants such as aluminum hydroxide, cocoabutter, kaolin, lanolin, zinc oxide or cod liver oil; astringents suchas witch hazel; analgesics such as Aloe vera and corticosteroids such ashydrocortisone and methylprednisolone.

Although the invention has been described and illustrated above withrespect of certain specific embodiments thereof it should be recognizedand understood that various alterations and modifications in the detailsof composition and use may be made without departing from the essentialspirit and scope of the invention as indicated by the appended claims.

1. A topical therapeutic composition comprising olive oil and betweenabout 0.001 and about 10% by volume of tea tree oil.
 2. The topicaltherapeutic composition of claim 1 comprising about 5% by volume of teatree oil.
 3. The topical therapeutic composition of claim 1 wherein saidolive oil is virgin olive oil.
 4. The topical therapeutic composition ofclaim 1 in the form of an aqueous emulsion.
 5. The topical therapeuticcomposition of claim 1 in the for of a form stable solid.
 6. A methodfor the palliative treatment of perianal irritation or inflammationwhich comprises applying to irritated or inflamed perianal tissue acomposition comprising olive oil and between about 0.001 and about 10%by volume of tea tree oil.
 7. The method of claim 6 wherein saidcomposition comprises about 5% by volume of tea tree oil.
 8. The methodof claim 6 wherein the olive oil of said composition is virgin oliveoil.
 9. The method of claim 6 wherein said composition is applied as anaqueous emulsion thereof.
 10. The method of claim 6 wherein saidcomposition is applied as a form stable suppository.